FacilitiesUtilitiesHVAC Lead

Seeking a CQV Lead specializing in facilities and engineering to oversee the qualification of building utilities clean utilities and environmental systems. This individual will be responsible for developing and executing commissioning qualification and validation (CQV) protocols to ensure regulatory compliance and to ensure traceability to design requirements.

Key Responsibilities:

Lead CQV efforts for facilities and utilities including HVAC water systems and building automation.

Develop and execute IQ/OQ/PQ protocols for clean utilities and facility systems.

Collaborate with engineering and project teams to align validation activities with construction schedules.

Ensure all validation doentation complies with regulatory standards (FDA cGMP).

Validation master planning

Conduct risk essments and develop mitigation strategies for potential compliance issues.

Provide crossfunctional support and expertise to other CQV activities as needed.

RequirementsQualifications:

Bachelor s degree in Engineering Life Sciences or a related field.

10 years of experience in CQV roles within pharmaceutical or biotech industries.

Expertise in facilities utilities and building management systems (BMS).

Strong understanding of FDA regulations and cGMP requirements.

At least 3 years experience/ knowledge with automated systems, including programming and improving complex systems Familiarity with at least one computer coding language (such as Python, Java, C#, HTML), understanding in version control systems (like GitHub or GitLab) is a plus Able to independently contribute through development and optimization of automation technologies preferred. Able to oversee implementation of automation technologies with third parties through technical ss and project management principles Must be able to work productively in an interdisciplinary team environment Experience with Hamilton, Scinomix, Tecan or similar automated laboratory platforms preferred Good oral and written communication, problem-solving, and ytical ss Ability to influence and educate other scientists and engineers to use automation technologies as part of implementation Proficiency using PC and Microsoft Office tools Excellent organizational and time management ss Strong attention to detail GMP and Good Doentation Practice Intermediate ss with WORD (authoring/editing large technical doents with styles, tables, TOCs, track changes) Basic ss with EXCEL and PowerPoint Experience with and tolerance for high levels of challenge and change Experience with project management including capturing project requirements and deliverables, timeline development, stakeholder management and communications

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